冻干麻疹腮腺炎风疹联合减毒活疫苗安全性观察  

Safety Investigation on Lyophilized Live Attenuated Measles-Mumps-Rubella Combined Vaccine

作　　者：陶红[1] 夏建华[2] 储艳[3] 方捍华[4] 李亚军[2] 王树巧[3] 马福宝[1] 

机构地区：[1]江苏省疾病预防控制中心,南京210009 [2]如东县疾病预防控制中心 [3]上海生物制品研究所 [4]中国药品生物制品检定所

出　　处：《中国学校卫生》2008年第9期829-831,共3页Chinese Journal of School Health

摘　　要：目的研究上海生物制品研究所的麻疹、腮腺炎、风疹三联联合减毒活疫苗（MMR）的安全性,为疫苗的使用提供科学依据。方法分Ⅰ、Ⅱ、Ⅲ期进行,分别选择7-15岁、8-18月龄儿童接种沪MMR,同时设进口MMR疫苗、麻疹疫苗、腮腺炎疫苗、风疹疫苗作对照,进行安全性观察。结果Ⅰ期7-15岁的11名接种沪MMR疫苗后,仅发生局部弱反应为27.3%;8-11月龄26名儿童接种沪MMR疫苗后,发热率和皮疹率分别为11.5%和15.4%,其中高热率为3.8%。Ⅱ、Ⅲ期观察1 188名8-18月龄儿童,沪MMR疫苗发热率为11.76%,皮疹率为3.64%,局部反应率为0.44%,其他反应率为0.33%。与对照疫苗比较,仅沪MMR疫苗发热率高于腮腺炎疫苗及风疹疫苗,差异有统计学意义,其他各反应差异均无统计学意义。结论沪MMR疫苗具有与目前使用的麻疹疫苗、腮腺炎疫苗、风疹疫苗及进口MMR疫苗相同的免疫安全性。Objective To study the safety of live attenuated measles-mumps-rubella combined vaccine（MMR） produced by Shanghai Biological Product Institute,and to provide scientific evidence for the use.Methods Children aged 7 to 15 years and 8 to 18 months were selected to be vaccinated with Shanghai MMR vaccine.Other groups of children with similar characters were vaccinated with measles vaccine,mumps vaccine,rubella vaccine or imported MMR vaccine as controls.The study was divided into three phases.Results During the phaseⅠ,among 11 children of 7 to 15 years who vaccinated with Shanghai MMR vaccine,27.3% of the children had the local side effect but with no other signs observed.Among 26 children of 8 to 11 months,11.5% of the children had fever,15.4% had signs of rash and 3.8% had high fever.Totally 1 188 children aged 8 to 18 months were observed during the phaseⅡand the phase Ⅲ.In the experiment group,11.76% of the children had fever,3.64% had signs of rash,and local side effect rate and other side effect rate was 0.44%,0.33% respectively.There was significant difference in fever rate between experiment group with Shanghai MMR vaccine and control groups with mump vaccine and rubella vaccine.Conclusion The Shanghai MMR vaccine is as safe as the measles vaccine,mump vaccine,rubella vaccine and imported MMR vaccine which have been used.

关 键 词：麻疹-腮腺炎-风疹疫苗 冷冻 安全 变态反应和免疫学 青少年 

分 类 号：R186[医药卫生—流行病学]